510(k) K800937
K800937 is an FDA 510(k) premarket notification submitted by R2 Corp. for the device "R2 PLATE TYPE CABLE-ADAPTOR #S 175,176". The FDA issued a decision of Substantially Equivalent on May 23, 1980. The device falls under product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)), a Class II device regulated under 21 CFR 870.5300. R2 Corp. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 1980
- Date Received
- April 21, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dc-Defibrillator, Low-Energy, (Including Paddles)
- Device Class
- Class II
- Regulation Number
- 870.5300
- Review Panel
- CV
- Submission Type